Chronic Low Back Pain Rehabilitation in Primary Care: an RCT

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02220543
• Date of registration: 14/08/2014
• Prospective Registration: No
• Primary sponsor: Maastricht University Medical Center
• Public title: Chronic Low Back Pain Rehabilitation in Primary Care: an RCT
• Scientific title: The Effectiveness of a Biopsychosocial Rehabilitation Program in Primary Care (Back on Track) Versus Primary Care as Usual in Patients With Chronic Low Back Pain in Which Psychosocial Factors Minimally Influence Daily Life Functioning: a Randomized Controlled Trial
• Date of first enrolment: August 2014
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02220543
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Netherlands

Contacts

• Name: Ivan PJ Huijnen, Dr.
• Affiliation: Maastricht University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Chronic low back pain; defined as pain between scapulae and gluteal region, whether or
not with radiation towards one or both legs, present for at least three months.

- Presence of contributing social and psychological factors, however not complex (WPN2
classification)

- Age between 18 and 65 year

- Sufficient knowledge of the Dutch language

- Acceptance towards the biopsychosocial approach instead of biomedical approach

Exclusion Criteria:

- Chronic low back pain attributable to e.g. infection, tumour, osteoporosis, fracture,
structural deformation, inflammatory process, radicular syndrome or cauda equina
syndrome

- Pregnancy

- Any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment
is better suited, according to the expert opinion of the consultant in rehabilitation
medicine.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Low Back Pain

Musculoskeletal Pain

Chronic Pain

Intervention(s)

Other: Back on Track intervention

Other: Primary care as usual

Primary Outcome(s)

Quebec Back Pain Disability Scale (QBPDS) [Time Frame: Change in functional disability between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up]

Secondary Outcome(s)

Social demographic questionnaire [Time Frame: pre-treatment]

Global Perceived Effect (GPE) [Time Frame: Global perceived effect at post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up]

Tampa Scale of Kinesiophobia [Time Frame: Change in kinesiophobia between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up]

Credibility and Expectancy Questionnaire (CEQ) [Time Frame: Directly after the first treatment (in the first week of the intervention)]

Pain Catastrophizing Scale (PCS) [Time Frame: Change in catastrophizing between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up]

EuroQol-5D (EQ-5D) [Time Frame: Change in quality of life between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up]

Hospital Anxiety and Depression Scale (HADS) [Time Frame: Change in anxiety and depression between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up]

Numeric Rating Scale (NRS) [Time Frame: Change in pain intensity between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up]

Pain Self-Efficacy Questionnaire (PSEQ) [Time Frame: Change in self-efficacy between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up]

Treatment questionnaire [Time Frame: Post-treatment (with an expected average of 8 weeks)]

Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P) [Time Frame: Medical consumption at pre-treatment (baseline), post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up after the end of the treatment]

Secondary ID(s)

14-3-019

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CZ Fonds

Adelante, Centre of Expertise in Rehabilitation and Audiology

The Province of Limburg